Effect of Gender Affirming Hormone Therapy on Glucose Metabolism

The University of Texas System (UT)

Status and phase: Enrolling; Early Phase 1

Conditions: Transgender Persons

Treatments: Drug: Botnia Clamp; Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04515472

HSC20190415H

Details and patient eligibility

About

The study will test:

1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function
2. whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function
3. whether estrogen therapy leads to enhanced immune response in older transwormen

Full description

All subjects will participate in a 2-hour oral glucose tolerance test (OGTT) and DXA scan for estimation of lean body mass. Only the transgender subjects will have a repeat OGTT two weeks after discontinuation of Gender Affirming Hormone Therapy (GAHT).

Beta cell function will be correlated with the Estrogen/Testosterone ratio to evaluate the relationship between sex hormones and beta cell function. Plasma Glucagon-like peptide 1 (GLP-1) response during the OGTT will be measured to evaluate if estrogen treatment modulates insulin secretion by increasing GLP-1 secretion.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers: healthy male or female
• MTF transgender
• FTM transgender
• Non-diabetic (A1c<6.5%), fasting glucose <126mg/dl and OGTT after 2 hr <200mg/dl)
• Stable hormone treatment (estrogen or testosterone) for at least 6 months

Exclusion criteria

• History of or newly diagnosed diabetes mellitus
• For healthy volunteers, not current treatment with estrogen or testosterone
• For FTM transgender, no recent cardiovascular event: acute coronary syndrome (ACS), stroke (CVA)
• For MTF and FTM transgender, less than 6 months of stable hormone treatment
• Anemia with hemoglobin (Hb) <11.0 hematocrit (Hto) < 34 and Glomerular Filtration rate (GFR) <30

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Healthy Volunteer Male

Active Comparator group

Description:

Healthy male currently on no testosterone treatment

Treatment:

Drug: Botnia Clamp

Healthy Volunteer Female

Active Comparator group

Description:

Healthy female currently on no estrogen treatment

Treatment:

Drug: Botnia Clamp

MTF group

Active Comparator group

Description:

MTF transgender currently on estrogen treatment

Treatment:

Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

Drug: Botnia Clamp

FTM group

Active Comparator group

Description:

FTM transgender group currently on testosterone treatment

Treatment:

Other: Withdrawal of Gender Affirming Hormone Therapy (GAHT)

Drug: Botnia Clamp